ISO 3826-3:2006 人类血液及血液成分用塑料可折叠容器.第3部分：带综合特征采血袋系统

标准编号：ISO 3826-3:2006

中文名称：人类血液及血液成分用塑料可折叠容器.第3部分：带综合特征采血袋系统

英文名称：Plastics collapsible containers for human blood and blood components — Part 3: Blood bag systems with integrated features

发布日期：2006-09

标准范围

ISO 3826-3:20 06规定了塑料、可折叠、不通风、无菌容器（血袋系统）上集成特征的要求，包括性能要求。集成功能指:白细胞过滤器；捐赠前采样装置；顶部和底部袋子；血小板储存袋；针刺保护装置。除了规定常规容器要求的ISO 3826-1:20 03之外，ISO 3826-3:20 06还规定了使用多个单元的血袋系统的附加要求。除非另有规定，ISO 3826-3:20 06中规定的所有试验均适用于准备使用的塑料容器。

ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems).The integrated features refer to:

• leucocyte filter;
• pre-donation sampling device;
• top and bottom bag;
• platelet storage bag;
• needle stick protection device.

In addition to ISO 3826-1:2003, which specifies the requirements of conventional containers, ISO 3826-3:2006 specifies additional requirements for blood bag systems using multiple units.Unless otherwise specified, all tests specified in ISO 3826-3:2006 apply to the plastic container as prepared ready for use.

标准预览图